LithoVue Elite Ureteroscope for Kidney Stones

(LVE Trial)

Recruiting at 7 trial locations

Overseen By Naeem Bhojani, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Pregnancy, Nephrostomy tube, Hydronephrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ureteroscope, a surgical tool for kidney stones, now equipped with a feature to measure pressure. The researchers aim to assess how this tool affects pain, quality of life, and infection risk after surgery. The trial targets individuals scheduled for ureteroscopy and laser lithotripsy with small kidney stones (totaling 2 cm or less). Those with non-blocking kidney stones set for this surgery may find this trial relevant. As an unphased trial, it offers a unique opportunity to contribute to medical advancements and improve surgical outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the LithoVue Elite ureteroscope is safe for kidney stone treatment?

Research has shown that the LithoVue Elite ureteroscope is generally as safe as other tools used for kidney stone procedures. Studies suggest it performs as well as traditional reusable and disposable scopes. A key feature is its ability to monitor kidney pressure in real-time, potentially reducing complications such as infections and pain. Although specific data on side effects is lacking, its approval by Health Canada indicates it meets safety standards for medical devices. Overall, current information suggests that the LithoVue Elite is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LithoVue Elite ureteroscope for treating kidney stones because it introduces an innovative, disposable design that reduces the risk of cross-contamination present in reusable scopes. Most standard treatments for kidney stones involve reusable ureteroscopes, which require thorough cleaning and sterilization between uses. The LithoVue Elite offers a single-use option, ensuring every procedure starts with a pristine instrument, enhancing patient safety and potentially improving procedural efficiency. Additionally, the flexibility and high-quality imaging of the LithoVue Elite may allow for better navigation and visualization during ureteroscopy, potentially leading to more effective stone removal.

What evidence suggests that the LithoVue Elite ureteroscope is effective for kidney stones?

Research has shown that the LithoVue Elite ureteroscope, used by participants in this trial, performs as effectively as other tools for treating kidney stones. It enables doctors to monitor kidney pressure in real-time, aiding in pain management and reducing infection risk during the procedure. One study found that it performs comparably to both reusable and other disposable ureteroscopes, facilitating effective visualization and removal of kidney stones during surgery. Overall, evidence supports its reliability as a tool for treating kidney stones. ^{1 5 6 7 8}

Who Is on the Research Team?

Naeem Bhojani, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for adults over 18 with kidney stones that are not causing a blockage and measure 2 cm or less in total diameter. It's not for those under 18, pregnant individuals, people with unusual kidney shapes, severe swelling of the kidneys, or those who have a tube inserted to drain their kidney.

Inclusion Criteria

I am older than 18 years.

I am scheduled for a procedure to remove kidney stones using lasers.

I have a kidney stone smaller than 2 cm and am getting a flexible ureteroscopy.

Exclusion Criteria

I have kidney abnormalities.

I am under 18 years old.

You are pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Preoperative assessments including imaging, questionnaires, and baseline measurements

1 day

1 visit (in-person)

Treatment

Ureteroscopy with LithoVue Elite ureteroscope and laser lithotripsy

1 day

1 visit (in-person)

Postoperative (1-2 weeks)

Stent removal and follow-up assessments

1-2 weeks

1 visit (in-person or virtual)

Follow-up

Standard of care imaging and assessment of stone-free rate and quality of life

4-8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LithoVue 2.0
• LithoVue Elite

Trial Overview The study is testing the LithoVue Elite ureteroscope—a new disposable scope with pressure sensing abilities—during surgery to remove kidney stones using lasers. The goal is to see how it affects pain levels, quality of life, and risk of infection.

How Is the Trial Designed?

Group I: Ureteroscopy (URS) with the LithoVue Elite disposable flexible ureteroscope Experimental Treatment 1 Intervention

Ureteroscopy will be done using the LithoVue Elite disposable flexible ureteroscope instead of the satandard ureteroscope

LithoVue 2.0 is already approved in United States, Canada for the following indications:

Approved in United States as LithoVue Elite for:

• Visualization of organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae)
• Diagnostic and therapeutic procedures in the urinary tract

Approved in Canada as LithoVue Elite for:

• Visualization of organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae)
• Diagnostic and therapeutic procedures in the urinary tract

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Laval University

Collaborator

Trials

439

Recruited

178,000+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

University of Saskatchewan

Collaborator

Trials

261

Recruited

156,000+

Published Research Related to This Trial

The LithoVue™ single-use flexible ureteroscope demonstrated comparable or superior performance in terms of flexion, deflection, and irrigation flow compared to reusable ureteroscopes, suggesting it is an effective alternative for urological procedures.

Switching to the LithoVue could lead to significant cost savings for hospitals, with cumulative costs for reusable scopes reaching approximately $50,000, while the single-use scope could reduce expenses to around $35,000, making it a financially viable option especially in high-risk cases for scope damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-use disposable digital flexible ureteroscopes: an ex vivo assessment and cost analysis. Hennessey, DB., Fojecki, GL., Papa, NP., et al.[2019]

The LithoVue single-use digital flexible ureteroscope demonstrated comparable maneuverability and visibility to conventional ureteroscopes in a study involving three surgeons testing four renal units in human cadavers.

While all ureteroscopes required a ureteral access sheath for effective kidney access, LithoVue was preferred for maneuverability in most procedures, indicating its potential utility in clinical settings, though further studies in live patients are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of New Single-Use Digital Flexible Ureteroscope Versus Nondisposable Fiber Optic and Digital Ureteroscope in a Cadaveric Model. Proietti, S., Dragos, L., Molina, W., et al.[2022]

The LithoVue™ digital flexible ureteroscope significantly reduces procedure time compared to reusable ureteroscopes, with average durations of 54.1 minutes versus 64.5 minutes, respectively, based on a study of 180 cases.

The scope failure rate for LithoVue was 4.4%, which is comparable to the 7.7% failure rate of reusable scopes, indicating that LithoVue is a safe and effective alternative for ureteroscopy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Case-Control Study Comparing LithoVue, a Single-Use, Flexible Disposable Ureteroscope, with Flexible, Reusable Fiber-Optic Ureteroscopes. Usawachintachit, M., Isaacson, DS., Taguchi, K., et al.[2022]

The LithoVue single-use digital flexible ureteroscope offers significant advantages over traditional reusable ureteroscopes, including reduced costs related to repairs and reprocessing, while maintaining high image quality and flexibility for effective treatment of kidney stones.

In a case study involving a 35-year-old female patient, the LithoVue ureteroscope successfully treated lower pole kidney stones without loss of deflection, demonstrating its efficacy and reliability in a challenging clinical scenario.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impressive Performance: New Disposable Digital Ureteroscope Allows for Extreme Lower Pole Access and Use of 365 μm Holmium Laser Fiber. Leveillee, RJ., Kelly, EF.[2020]

The LithoVue™ flexible ureteroscope demonstrated good image quality and maneuverability during a study of 40 procedures, with 65% of cases rated as having 'very good' image quality and 77.5% rated as 'very good' for maneuverability.

Despite its effectiveness, there were two instances (5%) of the LithoVue™ breaking during surgery, indicating a need for further evaluation of its durability and overall surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study. Doizi, S., Kamphuis, G., Giusti, G., et al.[2022]

In a study of 108 patients treated for renal stones using the single-use LithoVue™ flexible ureterorenoscope, 71.3% achieved complete stone removal in a single procedure, demonstrating its efficacy.

The device was associated with a low complication rate (7.4% of cases) and showed no significant differences in surgical outcomes between experienced consultants and less experienced residents, indicating it is user-friendly for surgeons of varying skill levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LithoVue™ for renal stone therapy - a perfect fit for high volume academic centers; a retrospective evaluation of 108 cases. Pallauf, M., Sevcenco, S., Steiner, C., et al.[2021]

Citations

1. bostonscientific.com bostonscientific.com/en-US/medical-specialties/urology/products/lithovue-elite.html

LithoVue™ Elite - Next-Gen Ureteroscope The LithoVue Elite Ureteroscope with IRP monitoring displays accurate, real-time, second-by-second, intrarenal pressure data directly on your current operating ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04900688

Prospective Evaluation of the LithoVue Elite Ureteroscope The single-use flexible ureteroscope (Lithovue Elite) will provide equivalent overall performance to a standard-of-care reusable or disposable ureteroscope as ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5057057/

LithoVue™: A new single-use digital flexible ureteroscope LithoVue is a new flexible ureteroscopy concept and is comparable with other ureteroscopes that already exist on the market in all basic characteristics.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5439446/

A Prospective Case–Control Study Comparing LithoVue, a ... Objective: LithoVue™ is a novel, single-use, digital flexible ureteroscope that was released to the US market in January 2016. There are scant data ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/17434440.2020.1848538

Device profile of the LithoVue single-use digital flexible ... Expert opinion: The LithoVue single-use flexible ureteroscope has comparable clinical performance to existing reusable ureteroscopes based on ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33307869/

Device profile of the LithoVue single-use digital flexible ... The LithoVue single-use flexible ureteroscope has comparable clinical performance to existing reusable ureteroscopes based on available data.

7. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.16173

Retrospective first‐in‐human use of the LithoVue™ Elite ... The system is comprised of the LithoVue™ Elite single-use digital flexible ureteroscope and StoneSmart™ connect console (Boston Scientific ...

8. urologytimes.com urologytimes.com/view/real-time-irp-monitoring-may-redefine-safety-and-scope-of-flexible-ureteroscopy

Real-time IRP monitoring may redefine safety and scope of ... LithoVue Elite's real-time IRP monitoring may expand ureteroscopy to larger stones, improving patient outcomes by reducing complications like ...